Kornimate/medical-research-clean huggingface dataset:
phase 3 study of alxn1850 in treatment-naïve pediatric participants with hpp

Conditions: Hypophosphatasia

Summary: the primary purpose of this study is to evaluate the efficacy of alxn1850 versus placebo on radiographic outcomes in pediatric participants with hpp who have not previously been treated with asfotase alfa.


Eligibility criteria:
inclusion criteria: * diagnosis of hpp documented in the medical records, and the following criteria fulfilled without other probable cause than hpp: 1. presence of hpp-related rickets on skeletal x-rays during the screening period, with a minimum rickets severity score (rss) of 1.0 and 2. serum alp activity below the age- and sex-adjusted normal range during the screening period as measured by the central laboratory or 2 documented serum alp activity results, at least 15 days apart, below the age- and sex-adjusted local laboratory normal range during the 24 months before the day 1 visit. note: local laboratories need to be clinical laboratory improvement amendments (clia) or iso 15189 certified, or have other local equivalent laboratory certification with alexion's approval. * must meet 1 of the following criteria: 1. documented alpl gene variant (pathogenic, likely pathogenic, or variant of unknown significance) from a clia certified laboratory (section 8.7) 2. plasma plp above the upper limit of normal (uln) during the screening period (central or local laboratory results allowed per local regulations) * tanner stage 2 or less during the screening period exclusion criteria: * history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological disorders, or any other disorders that are capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data as determined by the investigator * diagnosis of primary or secondary hyperparathyroidism * hypoparathyroidism, unless secondary to hpp * any new fracture within 12 weeks before day 1 (excluding pseudofractures) * planned surgical intervention which may impact the results of study assessments (in the opinion of the investigator) during the randomized evaluation period * history of allergy or hypersensitivity to any ingredient contained in alxn1850 or the placebo comparator

Keywords: hypophosphatasia hpp alxn1850
the role of antimicrobial foam dressing in prevention of cesarean section wound complications

Conditions: Cesarean Section; Complications, Wound, Dehiscence

Summary: post-cesarean section wound infections are responsible for longer hospital stays, readmissions, and ultimately, increased costs to the healthcare system. silver-containing dressings may prevent wound infections. the purpose of the current study is to determine if the use of a silver-impregnated dressing decreases the occurence of wound infection following cesarean delivery.

a single-centered, single-arm clinical trial was originally designed to investigate the effects of an adherent soft silicone anti-microbial occlusive foam silver-impregnated dressing in preventing surgical site infection (ssi) in women delivered by primary cesarean section (cs). we sought to determine if the incidence of ssis, would be lower in patients who received a silver-impregnated dressing as compared to those who received a standard dressing, when used as part of the overall hospital protocol for reducing ssis. given the addition of adjunctive azithromycin antibiotic prophylaxis for those who labored or had rupture of membranes prior to undergoing a non-elective cs right at the time of initiation of the study to our institution perioperative bundle, we also elected to undertake further analyses of observational data on those with the same study inclusion criteria receiving standard dressing undergoing primary cs with subcuticular skin closure during the same time period, rather than limiting comparisons of our outcomes solely to our historical ssi rates. in order to have this comparison group, patients who declined participation in the experimental groups were selected as our non-randomized control group, given fiscal restraints precluded conducting a randomized clinical trial (rct). demographic, labor, delivery, intraoperative and postoperative characteristic data were collected in a de-identified fashion. medical record review and data entry were conducted by trained research personnel. all study procedures were approved by the investigational review board.

Eligibility criteria:
inclusion criteria: * consent to undergo cesarean delivery * between the ages of 18 and 45 * primary c-section * subcuticular skin closure * able to consent, fill out study documents, and complete all study procedures and follow-up visits exclusion criteria: * patients with an allergy to silver * inability to obtain informed consent * staples * repeat c-section * vertical skin incision * intrapartum fever of 100f or \>

Keywords: pregnancy delivery cesarean section wound healing silver-containing dressing
medication integration in treatment of comorbid adolescent substance users/attention deficit hyperactivity disorder

Conditions: Attention Deficit Hyperactivity Disorder; Attention Deficit Disorder

Summary: the goal of this project is to develop and test a brief protocol designed to systematically integrate pharmacological interventions for attention deficit hyperactivity disorder (adhd) into behavioral treatment services for adolescent substance users with co-morbid adhd in everyday care. primary study aims will yield proof-of-concept data on mip feasibility and fidelity in usual care and evidence of mip impact on psychiatric and behavioral services utilization, medication acceptance and compliance, and satisfaction with treatment services.


Eligibility criteria:
inclusion criteria: * age 13-17 years * caregiver able to participate in treatment * one day of alcohol use to intoxication or illegal drug use in the past 30 days (or 30 days prior to living in a controlled environment) * endorsement of one or more dsm-iv symptoms of substance use or alcohol dependence/abuse * meet asam criteria for outpatient substance use treatment * meet dsm-iv criteria for adhd (with or without onset prior to age 7) * not enrolled in any behavioral treatment exclusion criteria: * mdd * bipolar disorder * mental retardation * pdd * medical or psychiatric illness requiring hospitalization * current psychotic features * currently suicidal

Keywords: comorbid adhd sud asu
the research about the acs after femoropopliteal arterial injuries

Conditions: Acute Compartment Syndrome

Summary: crural compartment syndrome is a well-known sequela after femoropopliteal arterial injuries in the lower extremity, particularly when there has been a long period of ischemia,need for ligation of a major vein, or when there is severe associated soft tissue.there is conteoversy in the treatment.


Eligibility criteria:
inclusion criteria: * patients with femoropopliteal arterial injuries * patients older than 18 years exclusion criteria: * patients who did not survive to discharge * patients with primary amputation * patients younger than 18 years

Keywords: acs femoropopliteal arterial injuries fasciotomy
migraine and neuropathic pain in osteoarthritis

Conditions: Osteoarthritis; Migraine; Neuropathic Pain

Summary: the goal of this observational study is to estimate the frequency of neuropathic pain and migraines in a group of patients with osteoarthritis of the knees, hips, hands, spine or other joints. in addition to their usual care for osteoarthritis, participants will complete questionnaires to define migraine and neuropathic pain.

this study will be proposed to patients with osteoarthritis who come for their routine consultation. if the patient has no abjection to taking part in the study, the doctor will give them the questionnaires to fill in. the questionnaires are about: perception of pain , depression and anxiety, how patients manage their disease emotionally, migraine, neuropathic pain, functional ability, osteoarthritis assessment.

Eligibility criteria:
inclusion criteria: * patients over 18 years old * patients with articular or/and spinal osteoarthritis * affiliation to a social security system. * able to read and understand french exclusion criteria: * patients who refuse to participate in the study * patients unable to complete self-questionnaires * minors or adults under the protection of the law or under the protection of justice

Keywords: osteoarthritis migraine neuropathic pain
changes in refractive error in patients with both partially refractive esotropia and amblyopia

Conditions: Refractive Errors; Esotropia; Amblyopia Strabismic

Summary: to investigate changes in refractive errors and evaluate clinical outcomes of strabismus surgery in patients with both amblyopia and partially refractive esotropia (paet).amblyopic patients with paet were enrolled. non-amblyopic patients with full refractive accommodative esotropia (raet) were included in the study as a control group. preoperative and postoperative best corrected visual acuity (bcva), spherical equivalent (se), astigmatism, stereoacuity and deviations at near and distance were evaluated and statistically compared in the patient group. the mean bcva, se, astigmatism were compared between the patient and the control groups.

purpose: to investigate changes in refractive errors and evaluate clinical outcomes of strabismus surgery in patients with both amblyopia and partially refractive esotropia (paet). material-method: amblyopic patients with paet were enrolled. non-amblyopic patients with full refractive accommodative esotropia (raet) were included in the study as a control group. preoperative and postoperative best corrected visual acuity (bcva), spherical equivalent (se), astigmatism, stereoacuity and deviations at near and distance were evaluated and statistically compared in the patient group. the mean bcva, se, astigmatism were compared between the patient and the control groups.

Eligibility criteria:
inclusion criteria: amblyopic children with partially refractive accommodative esotropia as study group non- amblyopic children with fully refractive accommodative esotropia as control group - exclusion criteria: systemic diseases neurological disorders and diseases additional ocular diseases
study to evaluate the association of testosterone levels with coronary artery calcification

Conditions: Coronary Artery Disease

Summary: coronary artery calcification (cac) is a pandemic condition in elderly patients with coronary artery disease (cad) and associated with worse prognosis. although available data shows association between testosterone levels in men and cad, the association between testosterone and cac in old-aged male patients with cad remains unknown. in this study, the relationship of serum testosterone levels with cac score in elderly male patients with cad was evaluated.

coronary artery calcification (cac) is associated with worse outcomes in patients with coronary artery disease (cad), especially in old-aged population. extensive cac also increases the risk of procedure associated complications, such as stent migration, coronary artery perforation, dissection and thrombosis. the pathogenesis of cac has not been fully explained. recent evidence suggests that cac share common pathways with bone formation. so, it can be presumed that risk factors contributing to bone formation and resorption activity also affect the development of cac. sex hormones is known to play an important role in bone development and in bone quality maintenance. available data shows that androgens may affect differentiation, proliferation, and apoptosis of osteocytes, osteoclasts, and osteoblasts. androgen receptor expression has been detected on different types of cells which contributing to the bone formation, such as osteoblastes, osteocytes and condrocytes, and androgen deprivation therapy results negative effects on bone mineral density in patients with metastatic prostate cancer. osteoporosis, a systemic disease characterized by bone tissue loss, is more prevalent in oler men with low testosterone levels. in cac, pathophysiological researches show that several vascular cell types, such as vascular smooth muscle cells, adventitial myofibroblasts and microvascular pericytes, have the potential to produce mineralized matrix and differentiate into osteoblasts. so, it can be postulated that androgens may play a similar role in the development of cac. up to date, only limited data is available about the association between testosterone and cac. a single-center study with relatively small sample revealed an inverse association between testosterone and cac in non-obese men. the aim of this study was to investigate the association between testosterone and cac measured as cac score in old-aged male patients with cad.

Eligibility criteria:
inclusion criteria: * elderly male patients (age ≥ 65 years old) with stable angina and proven coronary artery disease exclusion criteria: * less than 65 years old * acute coronary syndrome * history of pci or coronary artery bypass grafting * history of myocardial infarction * renal dysfunction defined by glomerular filtration rate \< 30 ml/min
evaluation of adm(sc derm® recon) in breast reconstruction

Conditions: Breast Cancer Female

Summary: the goal of this observational study is to examine any clinical differences in the outcomes of breast reconstruction surgeries using acellular dermal matrix (adm) processed by co2 supercritical fluid technology compared to other adm products that have been washed with detergents. the study will also assess safety outcomes.

the total number of study subjects is 100, with 50 people recruited prospectively into the test group and 50 people retrospectively into the control group. the test group will consist of 50 patients aged 20 to 80 who have undergone total mastectomy for breast cancer and are scheduled to undergo immediate breast reconstruction using implants. these subjects will receive sc derm (adm processed by dof inc.) during the implant-based breast reconstruction surgery. the control group will consist of 50 patients who will be retrospectively and consecutively selected from medical records of patients who underwent implant breast reconstruction using adm from other companies between june 1, 2021, and november 9, 2021. patients who fall into the following categories cannot participate in this clinical study because they meet the exclusion criteria: 1. patients who have received an organ transplant and are taking any immunosuppressants. 2. patients whose mental condition may affect the progress of the clinical study due to alcohol or drug abuse. 3. individuals who are unable to complete the survey conducted in this clinical study. 4. patients who participated in other clinical trials within the previous 120 days at the time of screening. 5. patients for whom the investigator determines participation in the study is not appropriate. among breast cancer patients who decide to undergo implant-based breast reconstruction after total mastectomy at our hospital, the investigator will fully explain the study to these patients during outpatient visits and recruit those who voluntarily express their willingness to participate. before any screening or enrollment, all subjects must confirm their willingness to participate by signing the informed consent form.

Eligibility criteria:
inclusion criteria: 1. patients aged 20 to 80 who undergo immediate breast reconstruction using implants after taking total mastectomy exclusion criteria: patients who fall into the five categories below cannot participate in this clinical study because they meet the exclusion criteria for research subjects. 1. patients who have received an organ transplant and are taking any immunosuppressant. 2. patients whose mental condition may affect the progress of clinical study due to alcohol or drug abuse. 3. people who are unable to complete the survey conducted in this clinical study. 4. patients who participated in other clinical trials within the previous 120 days at the time of screening. 5. if the investigator determine for a patient not to participate this clinical study since participation of the study is not appropriate.

Keywords: breast reconstruction using implants and adm
manual therapy for tension headache with psychological disorders

Conditions: Tension-type Headache

Summary: introduction. tension-type headache is a highly prevalent disorder with a significant socio-economic impact, affecting psychological aspects. this study aims to assess aspects pertaining to anxiety, depression, headache frequency and pain intensity. subjects and methods. a clinical trial was conducted on 84 participants suffering from tension-type headache, divided into 4 groups, the mean age being 39.76 years (sd 11.38). the first group received suboccipital soft tissue treatment (st); the second group was treated with articulatory technique (at); the third group was applied a combination of both techniques (st and at) and a forth group which served as control group. treatment sessions were administered during four weeks, with a post-treatment assessment, and follow-up after one month. the investigators conducted repeated measures analysis of covariance (rm-mancova) to evaluate the effect of treatment on between and within-subject conditions and their interaction on reported depression, anxiety, and headache pain frequency and intensity.


Eligibility criteria:
inclusion criteria: * patients participating in this study had been diagnosed in primary healthcare centers with frequent episodic tension-type headache (etth) or chronic tension-type headache (ctth) as described by the international headache society (ihs). participants presented pericranial tenderness evolving over a period greater than six months and all were pharmacologically stable. exclusion criteria: * exclusion criteria covered patients with secondary headache suffering from photophobia or phonophobia, nausea or vomiting, cases of headache aggravated by head movements, musculoskeletal disorders, previous neck trauma, vertigo, dizziness, arterial hypertension, arthritis or advanced degenerative osteoarthritis, patients with heart devices, excessive emotional tension, neurological disorders, radiological alterations, pregnancy and a positive vertebral artery test.

Keywords: tension-type headache depression anxiety manual therapy spinal manipulation patients diagnosed with tension-type headache
an open-label extension study to evaluate the safety and tolerability of licarbazepine in the treatment of manic episodes of bipolar i disorder.

Conditions: Bipolar I Disorder

Summary: this extension study is designed to investigate the long-term safety and tolerability of licarbazepine 750-2000 mg/day over 52 weeks in patients who completed the 3-week double-blind study clic477d2301.

a 52-week, open-label extension study to evaluate the safety and tolerability of licarbazepine 750- 2000 mg/day in the treatment of manic episodes of bipolar i disorder

Eligibility criteria:
inclusion criteria: 1. written informed consent provided prior to participation in the extension study 2. successful completion of study clic477d2301 3. willingness and ability to comply with all study requirements exclusion criteria: 1. premature discontinuation from study clic477d2301 2. failure to comply with the study clic477d2301 protocol

Keywords: bipolar disorder, manic episode/treatment/licarbazepine
atrial tachycardia as a predictor of atrial fibrillation, stroke and mortality in cryptogenic stroke

Conditions: Cryptogenic Stroke; Atrial Fibrillation; Atrial Tachycardia

Summary: there is few information about the association between supraventricular arrhythmia different from atrial fibrillation (af) or atrial flutter and the risk of stroke. in this study the investigators hypothesized that the presence of atrial tachycardia would lead to atrial fibrillation and recurrent stroke in patients hospitalized for cryptogenic stroke. the investigators study the association of atrial tachycardia (at), defined as four or more consecutive premature atrial beats, and af, recurrent stroke and cardiovascular mortality in 192 consecutive patients hospitalized because of cryptogenic stroke. the follow-up was 12 months for all population

the investigators review all consecutive patients that were hospitalized from stroke in our hospital (neurology department) between january 2010 and september 2013, and who had the diagnosis of cryptogenic stroke at discharge. all patients routinely underwent 24-hour ecg recording and an echocardiography during the hospitalization. the investigators have a global population of 210 patients who met these characteristics. the investigators analyze the presence of atrial tachycardia in 24-hour ecg register in patients with cryptogenic stroke. the investigators consider atrial tachycardia as four or more consecutive atrial ectopic beats. the investigators analyze baseline characteristics (cardiovascular risk factors, renal function, left atrial size _measured in m mode echocardiography in long paraesternal axis_ and total number of premature atrial complexes in the 24-hour ecg monitoring. the patients are stratified according to the presence or absence of atrial tachycardia in 24-hour ecg data. the investigators follow the clinical events (af, recurrent stroke or death) of patients from the electronical medical data of general physician and the re-hospitalizations for recurrent ictus in our hospital (which is the reference hospital of the zone) and mortality during 12 months.

Eligibility criteria:
inclusion criteria: * all consecutive patients that were hospitalized from stroke in our hospital (neurology department) between january 2010 and september 2013, and who had the diagnosis of cryptogenic stroke at discharge exclusion criteria: * patients with non-cryptogenic stroke * patients with haemorragic stroke * patients with terminal disease